Theravectys SAS, of Paris, was granted authorization by the National Security Agency for Medicines and Health Products in France and the Federal Agency for Medicines and Health Products in Belgium to launch a Phase I/II trial with its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology.

Aduro BioTech Inc., of Berkeley, Calif., said it completed enrollment in a Phase II trial of CRS-207 and GVAX Pancreas Cancer Vaccine eight months ahead of schedule. The vaccine regimen was given to patients with metastatic pancreatic cancer, and it was well tolerated with no unexpected adverse events. An interim analysis of safety and efficacy will be reported in the first quarter of 2013. Ariad Pharmaceuticals Inc., of Cambridge, Mass., published results of a Phase I trial of ponatinib in

Bayer AG, of Leverkusen, Germany, said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete. TRUST is designed to test the recombinant Factor VIIa protein in patients with hemophilia A or hemophilia B who have developed neutralizing antibodies. The study is composed of two parts: The first will involve sequential dose escalation for assessing dose response and

AesRx LLC, of Newton, Mass., said it plans to present data from its Phase I study of antisickling agent Aes-103 at the American Society of Hematology meeting in Atlanta. The data showed the drug is safe and well tolerated and suggested Aes-103 is biologically active in humans in a manner consistent with its proposed mechanism of action in sickle cell disease. The first-in-human, double-blind, placebo-controlled trial examined the effects of single doses of Aes-103 at 300 mg, 1,000 mg, 2,000 mg

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD). AC-1204 is a formulation of caprylic triglyceride designed to improve cognitive function in mild to moderate AD. The randomized, double-blind, placebo-controlled, parallel-group, multicenter trial will be conducted at 60 sites in the U.S. and is expected to enroll more than 400 patients. The study will evaluate the effects of once

The Journal of the American Academy of Dermatology published results from two pivotal trials by Valeant Pharmaceuticals International Inc., of Montreal, of efinaconazole 10 percent topical solution for onychomycosis, a nail infection caused by fungi. The primary endpoint of the randomized, double-blind, vehicle-controlled study enrolling 1,655 subjects was complete cure rate at week 52. In Study 1, 17.8 percent of subjects given efinaconazole achieved complete cure, compared to 3.3 percent of

MediciNova Inc., of San Diego, started enrolling a Phase IIa trial testing MN-166 (ibudilast) in prescription opioid or heroin abusers. The trial will be conducted at Columbia University and the New York State Psychiatric Institute and is funded by the National Institutes for Drug Abuse. MN-166 is a first-in-class, orally bioavailable small-molecule glial attenuator designed to suppress pro-inflammatory cytokines IL-1 beta, TNF alpha and IL-6, and may up-regulate the anti-inflammatory cytokine

Astex Pharmaceuticals Inc., of Dublin, Calif., said results from the dose-escalation portion of a Phase I/II study showed that SGI-110, a DNMT inhibitor, is well tolerated at doses higher than the biologically effective dose. Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with

Pfizer Inc., of New York, said top-line data from a Phase III study testing pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicated that the product had a statistically significant positive effect compared to placebo in the primary endpoint, defined as time to loss of therapeutic response. The trial is the second of three Phase III studies testing the CR formulation for once-daily therapy. The first study in partial onset seizures did not meet its primary endpoint

Pfizer Inc., of New York, said top-line results from a Phase III study testing the 165-mg dose and the 330-mg dose of pregabalin controlled-release (CR) formulation in adults with partial onset seizures showed that the trial did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well tolerated. The study is one of three Phase III trials designed to test pregabalin CR for use as a once-daily therapy. The other two studies are testing the

Adaptimmune Ltd., of Oxford, UK, said abstracts published in Blood reported encouraging preliminary results from an early phase study using patients' own T cells that have been genetically altered to attack multiple myeloma cells. The single-arm, open-label extension study is designed to test the safety, bioactivity and antitumor effects of the infusion of those T cells, which were genetically altered to express cancer testis antigens NY-ESO-1 and LAGE-1. The initial six patients have completed

Merck & Co. Inc., of Whitehouse Station, N.J., presented data from a post-hoc subgroup analysis of three studies, which found that integrase inhibitor Isentress (raltegravir) demonstrated consistent long-term viral suppression and a well-established safety profile in adults co-infected with HIV-1 and hepatitis C virus and/or hepatitis B virus, compared to adults with HIV-1, at 240 weeks. Data were presented at the International Congress on HIV and Drug Therapy in HIV Infection meeting in

Allon Therapeutics Inc., of Vancouver, British Columbia, said patient treatment has been completed in the multinational pivotal Phase II/III trial with davunetide as a potential treatment for progressive supranuclear palsy, a rapidly progressing and fatal degenerative brain disease. Allon is on track to release top-line data from the trial in the second half of December. AtheroNova Inc., of Irvine, Calif., said its Russian licensing partner, OOO CardioNova, formally submitted an

Bayer Inc., of Deerfield, Ill., and the Population Health Research Institute said they started the COMPASS trial, the largest clinical study to date of oral anticoagulant rivaroxaban. The Phase III study will investigate the prevention of major adverse cardiac events, including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or peripheral artery disease. About 20,000 patients will be enrolled.

Achillion Pharmaceuticals Inc., of New Haven, Conn., said that it completed a drug-drug interaction study of sovaprevir and ACH-3102 in 24 healthy volunteers, showing no interaction and that the compounds were safe and well tolerated. The drugs are being developed for hepatitis C virus. The company also reported additional proof-of-concept data from a Phase Ib trial of ACH-2684, for hepatitis C virus. In chronic genotype 1 patients, there was a mean maximum 3.67 log10 reduction in HCV RNA

Merck and Co. Inc., of Whitehouse Station, N.J., presented early interim results from a single-arm, open-label Phase Ib study of MK-3475, its investigational immune-modulating therapy, in advanced melanoma. Based on data for 85 of 132 patients enrolled in the study to date, 43 patients (51 percent) showed an objective antitumor response and eight patients (9 percent) showed a complete response at or after the 12-week assessment. Of 27 patients previously treated with ipilimumab (Yervoy, Bristol

Agenus Inc., of Lexington, Mass., reported that the second complete set of results from the Phase III trial of London-based GlaxoSmithKline plc's RTS,S malaria vaccine candidate (also known as Mosquirix), which contains Agenus' QS-21 Stimulon adjuvant, were published online in The New England Journal of Medicine and announced at the International Vaccines for Africa Conference in Cape Town, South Africa. The Phase III study met its primary endpoint and demonstrated statistically significant

Advanced Cell Technology Inc., of Santa Monica, Calif., said it has treated 13 patients thus far in its three ongoing trials for dry age-related macular degeneration and Stargardt's disease using human embryonic stem cell-derived retinal pigment epithelial cells. The first two trials began in July 2011. The three clinical trials involve four of the top-ranked eye hospitals in the U.S., and two of the leading eye hospitals in the UK. Across the various clinical trial sites, with regular patient

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, disclosed interim results from the RELY-ABLE trial, a long-term extension of the RE-LY study. During more than two years of randomized follow-up, key safety outcomes such as major bleeding, total bleeding and life-threatening bleeding were similar to the results of the dabigatran 110-mg and 150-mg arms of the pivotal RE-LY trial that evaluated Pradaxa (dabigatran etexilate mesylate) capsules in